Pancreatic Cancer and Thyroid Cancer Risks with Dulaglutide Treatment

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DULAGLUTIDE
• Medical condition to be studied:
  Diabetes mellitus
• Additional medical condition(s):
  Type 2 Diabetes Mellitus

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  140000

Study design details

• Main study objective:
  Compare the risks of pancreatic cancer among initiators of dulaglutide compared to initiators of other second-line anti-hyperglycemic drugs. Compare the risks of thyroid cancer (including medullary thyroid carcinoma) among initiators of dulaglutide compared to initiators of other second-line anti-hyperglycemic drugs.
• Outcomes:
  Pancreatic Cancer Thyroid Cancer, Medullary Thyroid Carcinoma
• Data analysis plan:
  Propensity Matched and High-Dimensional Propensity Analyses will be applied to estimate Hazard Ratios and Confidence Intervals.